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Characteristics and Outcomes of Candidemia in Patients with Durable Left Ventricular Assist Device Support
In conclusion, fungemia is a rare and severe complication in LVAD patients occurring early postimplant.
Source: ASAIO Journal - August 1, 2022 Category: Medical Devices Tags: Adult Circulatory Support Source Type: research

Increased Rate of Pump Thrombosis and Cardioembolic Events Following Ventricular Tachycardia Ablation in Patients Supported With Left Ventricular Assist Devices
Ventricular arrhythmias are common following left ventricular assist device implantation (LVAD), and the effects of ventricular tachycardia (VT) ablation on thrombosis and embolic events are unknown. We aimed to assess LVAD thrombosis, stroke, and embolic event rates after VT ablation. Left ventricular assist device implantation patients from two academic centers who underwent endocardial VT ablation between 2009 and 2016 were compared to a control group with VT who were not ablated and followed for one year. The primary composite outcome was confirmed or suspected LVAD thrombosis, stroke, or other embolic event. Survival ...
Source: ASAIO Journal - November 1, 2020 Category: Medical Devices Tags: Adult Circulatory Support Source Type: research

Adagio Gives Afib Cold Treatment in Hot Market
Adagio Medical is vying to get its treatment for persistent atrial fibrillation treatment on the market. The Laguna Hills, CA-based company made significant progress toward the goal this week and announced it received an IDE from FDA. The firm is developing a catheter procedure involving an energy source that freezes tissue. Adagio said its intelligent continuous lesion ablation system (iCLAS) encompasses the One- Shot+ catheter, a corresponding console, and a protective esophageal balloon to mitigate the effects of the cold beyond the localized area of ablation. The anatomical approach requires a single transseptal punctu...
Source: MDDI - August 20, 2019 Category: Medical Devices Authors: Omar Ford Tags: Cardiovascular Business Source Type: news

Predict and Prevent: The Emergence of Real-Time Sensor-Based Care
Technology industry veteran Eran Ofir knows there is a lot of luck involved in successfully bringing a new device, especially one designed to create a new treatment vector, to market. Ofir is the CEO and co-founder of New York-based Somatix, which uses wrist-worn sensor data to dynamically monitor a person's situation. Used in conjunction with cloud-based computing resources and a communications device, the technology is capable of dynamically helping someone quit smoking, through detecting smoking gestures and automatically sending messages to the user encouraging them not to smoke. "We got lucky on two fronts," Ofir said...
Source: MDDI - December 19, 2018 Category: Medical Devices Authors: Greg Goth Tags: Digital Health Source Type: news

Boston Scientific puts $270m on the table for Claret Medical
Boston Scientific (NYSE:BSX) said today that it agreed to pay as much as $270 million to acquire Claret and its Sentinel device. Marlborough, Mass.-based Boston Scientific said the deal involves an ip-front cash payment of $220 million and another $50 million pegged to a reimbursement milestone. Claret’s Sentinel device is designed to trap and remove debris dislodged during transcatheter aortic valve replacements to prevent stroke and other neurological damage. After landing CE Mark approval in the European Union in 2014, Santa Rosa, Calif.-based Claret won de novo clearance from the FDA last year for the Sentinel d...
Source: Mass Device - July 20, 2018 Category: Medical Devices Authors: Brad Perriello Tags: Mergers & Acquisitions Replacement Heart Valves Wall Street Beat Boston Scientific Claret Medical Inc. Source Type: news

Real World Data Could Give Edwards Edge in TAVR
Edwards Lifesciences is continuing to strengthen its position in the transcatheter aortic valve replacement(TAVR) market by revealing real world data for the Sapien 3 valve. The Irvine, CA-based company presented positive 30-data of the device at EuroPCR. The propensity-matched analysis compared real-world data collected from the Society of Thoracic Surgeons and American College of Cardiology (STS/ACC) Transcatheter Valve Therapy (TVT) Registry with outcomes of patients enrolled in the PARTNER II studies of the Sapien 3 valve. Nearly 2,000 patients were involved and treated in more than 450 commercial centers around the U....
Source: MDDI - May 22, 2018 Category: Medical Devices Authors: Omar Ford Tags: Cardiovascular Business Source Type: news

Bioelectronic Medicine: Targeting Inflammatory Disease with Electricity
We presented positive initial results in Crohn’s disease at the 2016 United European Gastroenterology meeting: six of the eight patients had seen a substantial reduction in their disease activity index scores, and three were in remission from the disease. As SetPoint looks ahead, several chronic disease areas are emerging as key bioelectronic medicine therapy targets, and our company is exploring a number of these. One of our preclinical programs explores bioelectronic medicine’s potential role as a treatment for MS.   New Target: Multiple Sclerosis In late 2017, SetPoint presented positive data from a study exp...
Source: Mass Device - April 17, 2018 Category: Medical Devices Authors: Anthony Arnold Tags: Bioelectronic Medicine Clinical Trials Neuromodulation/Neurostimulation SetPoint Medical Sponsored Content Source Type: news

Making AI Matter in Healthcare
Healthcare is just as prone to fall victim to hype and irrational exuberance as any other complex industry. And the more revolutionary the promise, the more outrageous the overstatements could be. Artificial intelligence has certainly been one of those "next big things" for some time in healthcare. Whether branded as "big data and analytics" or "automated clinical decision support," the results of technology-assisted care, especially in non-clinical and non-emergent settings, have been uneven at best. But a new report indicates AI's time in healthcare is nigh, and technology and policy pioneers are doing their best to ensu...
Source: MDDI - March 9, 2018 Category: Medical Devices Authors: Greg Goth Tags: Software Digital Health Source Type: news

FDA approves pivotal study of Vascular Dynamics MobiusHD high blood pressure device
Vascular Dynamics said today that the FDA approved an investigational device exemption for a clinical trial of its MobiusHD device for treating resistant hypertension. MobiusHD is designed to help regulate blood pressure using electrodes implanted in the carotid artery to stimulate baroreceptors there. Mountain View, Calif.–based Vascular Dynamics said the 300-patient Calm 2 study is designed to compare treatment with MobiusHD and a sham procedure. The primary safety endpoint is a composite of death, myocardial infarction, stroke, device embolization, carotid occlusion, new ipsilateral carotid stenosis requiring surgic...
Source: Mass Device - August 15, 2017 Category: Medical Devices Authors: Brad Perriello Tags: Cardiovascular Clinical Trials Food & Drug Administration (FDA) Regulatory/Compliance vasculardynamics Source Type: news

Organovo CEO Murphy steps away, Crouch steps up | Personnel Moves – April 14, 2017
Organovo (PINK:ONVO) said earlier this week that Taylor Crouch has been appointed as CEO, replacing Keith Murphy who is stepping away from the company. The changes are slated to go into effect on April 21. Prior to being tapped for  the corner office, Crouch operated as CEO of investigative clinical research company eStudySite, the San Diego, Calif.-based company said. “I am extremely proud of the progress we have made in the last ten years achieving our vision for Organovo.  Our 3D bioprinted human tissues are a disruptive and game-changing technology.  Founding Organovo and guiding us to our leadership position...
Source: Mass Device - April 14, 2017 Category: Medical Equipment Authors: MassDevice staff Tags: Business/Financial News Active Implants AdvaMed Alphatec Holdings Inc. Anika Therapeutics Inc. Apollo Endosurgery Aurora Spine Baxter Biocorp Biogen Idec Biolase Technology Inc Bioventus LLC Bonesupport Clal Biotech Delcath Sys Source Type: news

Nico launches trial for brain surgery shunt
Nico Corp said today it enrolled the 1st patient in the Enrich clinical trial which aims to explore the use of its BrainPath Approach for treating intracerebral hemorrhages. The trial will examine the procedural safety as well as economic and functional benefit of early surgical removal of intracerebral hemorrhages using its BrainPath Approach system. “Our initial clinical results with this approach for early clot removal have been exciting and provided a wake-up call to what has been missing in hemorrhagic stroke care,” trial principal investigator Dr. Daniel Barrow said in a press release. Indianapolis, I...
Source: Mass Device - January 10, 2017 Category: Medical Equipment Authors: Fink Densford Tags: Clinical Trials Neurological Nico Corp. Source Type: news

TAVI: Boston Scientific’s Lotus valve tops Medtronic’s CoreValve – study
Data from a study of Boston Scientific‘s (NYSE:BSX) Lotus Valve showed a greater device success rate than Medtronic‘s (NYSE:MDT) CoreValve in high-risk transcatheter aortic valve replacement patients. The single-center, non-randomized study, published this month in the journal JACC: Cardiovascular Interventions, compared outcomes from 50 high-risk TAVI patients treated with the Lotus valve and 50 similar patients treated with Medtronic’s self-expanding CoreValve device. Success rates were higher at 30 days in the Lotus group, at 84%, versus 64% with CoreValve, according to the study.  These results...
Source: Mass Device - June 17, 2015 Category: Medical Equipment Authors: Fink Densford Tags: Cardiovascular Clinical Trials Replacement Heart Valves Boston Scientific JACC: Cardiovascular Interventions medtronic Source Type: news

Board #153 - Research Abstract The Creation of a Simulator Value Index Tool by Connected Consensus (Submission #8590).
Conclusion: The product from this work (SVI Worksheet tool) can be applied aid the simulator purchase process across countries, institutions, and stakeholder. We are hopeful that simulator purchase processes might include the SVI Worksheet with the intention to maintain alignment with educational goals, while still accounting for other factors considered at the institutional level. At the same time, common measures might facilitate future communication across academic medical institutions and simulator industry. More evaluation is required following broad-scaled implementation. References: 1. Britt RC, Novosel TJ, Britt LD...
Source: Simulation in Healthcare: The Journal of the Society for Simulation in Healthcare - December 1, 2014 Category: Medical Equipment Tags: Abstracts: 2ND PLACE AWARD WINNER: PDF Only Source Type: research